FDA Inspection
Ashaway Line & Twine Mfg. Co.Ashaway Line & Twine Mfg. Co. – FDA Inspection, Oct 28, 2009
Record Details
This FDA Inspection record concerns Ashaway Line & Twine Mfg. Co., with an inspection on October 28, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 28, 2009
- Product Type
- Devices
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ID · d7efe549-8580-4b87-883c-50acedaf16d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 630767
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(g)(1)Activity documentation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.181(b)DMR production process specifications
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Other FDA inspections of Ashaway Line & Twine Mfg. Co.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 6, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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